The urinary bladder dysfunction problems are widespread and common. The symptoms could range from mild irritative ones in the early stage of various diseases to the debilitating ones in the later stages of the disease. The symptoms usually include urinary frequency, urgency and nocturia (waking up at night to go to the bathroom to void) with or without urge incontinence. Therefore the need to increase awareness amongst the medical community as well as the public about the availability of treatment for those ailments would dramatically improve the people's quality of life since early intervention will obtain good results as well as arresting the progression of disease, which in turn will prevent reaching the refractory and debilitating conditions that has the potential to incapacitate many people.
Urinary Bladder Dysfunction Problems that could Benefit from the invention described below which deals with the Controlled Hydrodistention of the Bladder (CHDB):
1. Overactive Bladder (OAB) Subsets of this Disorder Include:
                a) Overactive bladder dry        b) Overactive bladder wet        c) Refractory overactive bladder        
The symptoms of overactive bladder (OAB) include urgency, frequency and nocturia with or without urge incontinence. Urgency is defined as the sudden compelling desire to void that is difficult to defer. It is estimated that 17% of the population or about 33 million Americans experience symptoms of overactive bladder. The diagnosis can be made after complete history and physical examination, urinalysis, review of the bladder diary, measurement of post void residual urine, cytology, uroflowmetry and cystoscopy. Organic causes of urinary symptoms should be ruled out such as urinary tract infection, stones, obstruction and cancer etc. Urologists are familiar with the workup of the evaluation and management of those problems. Once overactive bladder diagnosis is made, then behavior modification in the form of fluid intake restrictions and pelvic floor exercises in addition to controlled bladder hydrodistention should help many of those patients in alleviating their distressing symptoms.
The current treatment used nowadays and the drawbacks:                a. Antimuscarinic medications may help in some patients; however the disadvantages include high cost, tolerance which requires increase of the dosage or change of the medicine and multiple side effects that include dry mouth, constipation, dizziness, confusion and loss of the brain cognitive function especially in the elderly population and potential cardiac side effects. All of the above lead to high percentage of drop outs. In fact, it is estimated that out of one thousand patients taking medication, only two hundred will continue medication after one year, a mere 20%, in other words, the drop out percentage rate is about 80%. Our novel device would eliminate all those potential side effects and complications.        b. Neuromodulation (Interstim) an invasive, costly, surgical procedure with limited effectiveness and in many cases disappointing long term results.        c. Botox involves injection of Botulinum toxin into the bladder (not FDA approved as of the date of this patent application) is a costly, invasive procedure with lack of uniform results and potential complications such as muscle weakness, aggravation of symptoms following multiple injections, and development of resistance.        d. Highly invasive and costly surgical procedures that occasionally are used in advanced debilitating conditions. Those procedures include augmentation cystoplasty, detrusor myomectomy, and cystectomy with diversion. All those procedures are extremely invasive and carry with them the potential risks and complications of major surgery. Our novel device should help many of those patients and could be an integral part of multimodal approaches to the difficult problems. However, we must stress here again that the increased awareness should allow many patients problems to be handled in their early stages when their results are better and more sustainable.        
In brief, controlled hydrodistention of the bladder (CHDB) as a first line intervention in overactive bladder may actually produce an affect on unmyelinated C-fibers in the bladder producing local differentiation and thus help the overactive bladder symptoms. The potential risks of hydrodistention of the bladder may involve infection which can be reduced by antibiotic premedication, transient hematuria which usually subsides spontaneously. A bladder tear should be extremely rare since the entire procedure is performed under a strict set of scientific parameters and the fact that the entire procedure is performed with a sterile and closed system should allow simple catheter drainage to be all that is needed to handle this complication should it ever occur.
2. Interstitial Cystitis (IC) and Chronic Pelvic Pain Syndrome (CPPS) in Women.
This common syndrome is characterized by the symptoms of urgency and frequency of urination in addition to pelvic pain. It is estimated that 38% of women presenting to their physician for chronic pelvic pain syndrome have interstitial cystitis. CPPS is believed to occur in as many as 1 in 4.5 women in the USA. The total annual cost for CPPS was estimated in 1996 to be approximately 2.8 billion dollars in addition to about 500 million dollars in lost work time. The symptoms range from mild early on to severely debilitating in advanced cases. The symptoms could include generalized pelvic pain in the lower abdomen, urethra, perineum, pain with intercourse and pain with bladder filling. The voiding symptoms include frequency, urgency, nocturia and premenstrual exacerbations. The results are reduced quality of life, emotional distress, depression and disruption of normal activities and social relationships. Several treatment approaches are used to manage IC/CPPS including cystoscopy and hydrodistention of the bladder under anesthesia, however the lack of scientific standards and the lack of control parameters limit the use of this procedure. Since there have been no standard methods of bladder hydrodistention, the results vary markedly, and make it difficult to replicate the better results of some centers. The use of our novel device would in effect introduce the scientific and standard parameters required to replicate the good results in various centers by different operators. We should again emphasize that the increased awareness of using the novel device in the early stages of this disease could help immensely with many patients, as well as the potential to arrest the disease progression.
3. Chronic Prostatitis (CP) and Chronic Pelvic Pain Syndrome (CPPS) in Men.
Other terminology includes chronic nonbacterial prostatitis and prostatodynia. There is an understanding that CP/CPPS is a form of IC/OAB syndrome. The predominant symptom is pain most commonly localized to the perineum suprapubic area and penis. It can also occur in the testes, groin or low back. Pain that occurs during or after ejaculation is the dominant symptom in some patients. Many patients experience lower urinary tract symptoms (LUTS) in the form of urgency, frequency, hesitancy in addition to poor and interrupted flow of urine. Some patients will also experience erectile dysfunction (ED). Many of these patients have significant impairment of the quality of life. Currently there is no uniformly effective treatment, and hence the prolonged suffering of those patients. The use of multiple ineffective medications leads to considerable drop in the quality of life, decreased productivity, depression and other social problems. The novel device should help many of those patients ameliorate symptoms and put many of them on the road to recovery. Again we must stress that public awareness and early interference should reward many of those patients with improvement in all aspects of their life.
4. Mixed Urgency and Stress Urinary Incontinence in Females
Stress urinary incontinence is defined as loss of urine control upon increase in intra abdominal pressure, such as in coughing, sneezing or heavy lifting. This is a very common urologic problem in female patients. However, if the stress incontinence is associated with urinary frequency, urgency and nocturia with or without urgency incontinence, now the condition is termed mixed urgency and stress urinary incontinence. It is understood that this is a combination of stress urinary incontinence and overactive bladder (OAB). Once the patient evaluation is completed and other organic causes are ruled out and the overactive bladder symptoms are the predominant feature, then surgical intervention to correct the stress urinary incontinence component may not be helpful at all. In fact, it could intensify that patient's symptoms, therefore in this category of patients treatment should be directed at the overactive bladder component. Controlled hydrodistention of the bladder (CHDB) will help control the OAB symptoms and in fact could improve the stress urinary incontinence component and avoid unnecessary and potentially harmful surgical intervention. In addition, for those patients who had surgical intervention for the stress incontinence component, using the novel device to perform controlled hydrodistention of the bladder could help in controlling the urgency incontinence component. Large scale clinical studies again should standardize the approach and validate the procedure.
5. Benign Prostatic Hypertrophy (BPH) Associated with Overactive Bladder (OAB)
It is understood that BPH occurs in 50% of male patients age 50, in 60% of male patients age 60, 70% of male patients age 70 and 80% of male patients age 80. Approximately 50% of male patients with BPH have symptoms related to overactive bladder (OAB). They symptoms of frequency, urgency with or without urge incontinence, as well as nocturia should alert the treating physician of the existence of OAB in these patients. When the complete clinical evaluation reveals no bladder outlet obstruction or minimal to borderline bladder outlet obstruction from the prostate, the rush to perform ablative surgery for the prostate could have detrimental consequences by adding post prostatectomy urinary incontinence, in addition to the overactive bladder symptoms. When the clinical evaluation reveals that the OAB symptoms predominate or when the situation is borderline, the use of the novel device and performing CHDB could improve the patient's symptoms and avoid unnecessary surgery and its potential complications and expense. The availability of the novel device will assist in conducting proper large scale clinical studies to further validate its usefulness in such patients. Controlled hydrodistention of the bladder could also be used in the unfortunate patient who already had prostate surgery and continues to have the OAB symptoms, therefore avoiding the use of medications with the inherent expense and side effects.
6. Nocturnal Eneuresis and Diurinal Eneuresis in Children and Adolescents
Eneuresis is defined as involuntary voiding, nocturnal eneuresis is nighttime bedwetting, and diurinal eneuresis is daytime wetting. Nocturnal eneuresis occurs in approximately 15% of children at age 5. By age 7, children are expected to be dry. Nocturnal eneuresis is approximately 50% more common in boys than in girls. The complete clinical evaluation should disclose any organic causes of eneuresis. Once no organic cause is found, it is believed that those patients have an element of OAB. Similar conclusions could be drawn from the clinical workup of patients with diurinal incontinence. Currently the available treatment includes medications such as Imipramine and DDAVP Desmopressin. Side effects of Imipramine may include sleep disturbance, appetite changes, GI symptoms, nervousness and personality changes which could lead to termination of treatment. DDAVP adverse effects could range from nasal irritation when nasal spray is used, to potential serious effect of water intoxication and hyponatremic seizures, again leading to discontinuation of therapy. Many physicians use those medications in addition to bladder training and conditioning therapy using a urinary alarm; however the results are usually modest. Frustration of the child and parents could develop due to the prolonged management, lack of success and considerable treatment side effects. Here again, the use of our novel device and performing CHDB could have far better results. Again large scale properly conducted clinical studies should validate the device's usefulness and establish the scientific standards and parameters for this approach.